2023学年完整公开课版Inspectionofvisibleforeignbodies

PharmaceuticalAnalysisInspectionofvisibleforeignbodiesInspectionofvisibleforeignbodies石磊MastertheconceptandsignificanceoftheexaminationofvisibleforeignbodycontentFamiliarwiththedeterminationofvisibleforeignbodiesUnderstandtheresultsofthevisibleforeignbodytest.PurposeandsignificanceDefinitionofvisibleforeignbodiesVisibleforeignmatterreferstoaninsolublesubstance,usuallylargerthan50minsizeorlength(exogenousorendogenous),whichispresentininjectionsoreyedropsandcanbeobservedvisuallyunderspecifiedconditions.Categoriesofvisibleforeignbodies1.Exogenoussubstances:Fiber,metalchips,glasschips,etc2.Endogenoussubstances:Theinsolublematterrelatedtorawmaterials,precipitatesafterdrugplacement,etcSignificanceofvisibleforeignbodyexamination1.ClinicalsignificanceCompleteexamination(anaphylaxis,microcirculationdisturbance,vascularembolism,etc.)2.SignificanceofproductionIndirectinspectionandcontrolofproductionenvironment,containertreatment,dosageformprescriptionandotherfactorsMethodsfortheexaminationofvisibleforeignbodies1.TheinspectionmethodAcontinuationandimprovementoftheclassics,commonlyused2.LightscatteringmethodInordertomeettheneedsofmoderninspection,thismethodshouldbeusedforthevarietiesthatarenotsuitablefortheinevitablelampinspectionduetothedevelopmentofscienceandtechnologyExperimentalconditions:1.Device:Calibrationinstrumentwithadjustableilluminationandblackandwhitebackground2.Personnel:visiontest4.9orabove(5.0oraboveaftercorrection);Nocolorblindness3.Thecolorlesstestsolutionpackagedinacolorlesstransparentcontainershallhavealuminanceof1000~1500lx;4.Theilluminanceoftestsolutionorcoloredtestsolutionpackedintransparentplasticcontainerorbrowntransparentcontainershallbe2000~3000Lx;5.Theluminanceofthesuspensiontestproductoremulsionshallbe4000lx.LightinspectionmethodTheexperimentaloperationInthedarkroom,takethetestproductandplaceitattheedgeofthecanopydevice.Undertheprescribedlightingconditions,holdthetestproductandgentlyturntheliquidoverattheneckofthebottleundertheblackandwhitebackgroundrespectively(thedistancebetweenthetestproductandthehumaneye,whichisusually25cm).Repeat3timeswithatotaltimelimitof20seconds.Ifthequantityofeachsampleis10mlorless,twopiecescanbeheldeachtimeforexamination.Theinjectionof50mlormorewasrotatedinthreesteps:straight,horizontalandinverted.LightinspectionmethodLightdetection-resultjudgmentTheclasstypeAtthebeginningoftryAftertestSolutionforintravenousinjectionandconcentratedsolutionforinjection20pieces(bottles)shallnotbecheckedout.Ifthereisonlyonefineforeignbodyvisible

Takeanother20pieces(bottles)forthesecondtest.Noneofthemcanbedetected

Solutiontypenon-intravenousinjection20pieces(bottles)shallnotbecheckedout.IfafineforeignbodyisdetectedTakeanother20pieces(bottles)forthesecondtest.Primaryandsecondarytests≤2pieces(bottles)

Solutioneyedrops20pieces(bottles)shallnotbecheckedout.IfafineforeignbodyisdetectedTakeanother20pieces(bottles)forthesecondtest.Primaryandsecondarytests≤3pieces(bottles)Suspension,emulsioninjectionandeyedropsNoobviousforeignbodyshouldbedetectedin20bottlesNothingLightinspectionmethodDecisioncriteria1.AllkindsofinjectionsandliquidophthalmicpreparationsAfterstandingforacertaintime,thecolumnofsmokeparticlesshouldnotbedetectedwhengentlyrotating,andnoobviousforeignbodiesshouldbedetected.2.Noobviousforeignbodies:metalchips,glasschips,fibers(hairs)oflengthormaximumdiameterexceeding2mmandlumps,etc.A